Priority New Monograph Items
USP is seeking sponsors to aid in developing the following prioritized list of Chemical Medicines monographs that are not part of the official USP and are therefore considered missing. The list contains drug substance and drug product monographs that we estimate generic market entry to be within 5 years. These articles have been approved by the FDA and are published in the Approved Drug Products with Therapeutic Equivalence (Orange Book). Visit the below links to view, download, or print the current lists:
- Small Molecules Activities - Drug Substances (as of 30-Sep-2014)
- Small Molecules Activities - Drug Products (as of 30-Sep-2014)
- Inactive Ingredients (as of 30-Sep-2014)
A small number of monographs on this list may be under development because USP accepts pending monographs from sponsors awaiting FDA approval of their article. Monographs marked as “Received as Pending” are in development but have not yet advanced to a draft posted on the USP Pending Webpage. Draft pending monographs marked as “Posted as Pending”, are posted on the USP Pending Webpage with a link provided for each entry.
If you are interested in becoming a sponsor for these products, please contact the Standards Acquisition Department at email@example.com. For other relevant useful information, please consult the following:
- For an overview of the monograph submission process, refer to USP’s Monograph Submission Guidelines at https://www.usp.org/usp-nf/development-process/submit-new-monographs/submission-guidelines.
- To register and file your submission electronically, visit the Donor Submission Portal at https://donors.usp.org/donor/logon.do.
- For additional questions, contact Randy Kiser MS MBA, Program Manager at firstname.lastname@example.org.
Thank you for your continued interest and support of the USP’s standards-setting process.